The primary objective of this research is to study the efficacy and safety of daily, home-based hyperthermic baths for reducing epileptic seizures in CDKL5 Deficiency Disorder.
A diagnosis of CDKL5 deficiency disorder, including molecular confirmation of a pathogenic CDKL5 variant and exhibiting epileptic seizures.
Male or female participants aged 6 months to 14 years, inclusive.
Patients presenting with drug-resistant epilepsy that seizures were uncontrolled despite the appropriate trial of at least two antiseizure medications (ASMs).
At least 8 motor seizures during each 4 weeks in the 8-week historical seizure records preceding screening.
Patients who had any history of previous brain disease (including trauma, encephalitis, etc.) that were likely to precipitate seizures; defined by MRI outcomes.
Participants with skin ulceration or dermatologic conditions that make bathing unsuitable.
Parents or guardians who, based on past experiences, determine that the child has an intolerance to thermal baths.
A history of seizures induced by thermal baths, or an increase in seizure frequency after thermal baths.
Parallel
Home-based hyperthermic Baths
BehavioralA 12-week daily home-based hyperthermic bathing intervention consisting of immersion in a 40-42°C water bath for 20 minutes per session under continuous parental supervision. The intervention will be administered according to the study protocol.
Seizure Responder Rate
The proportion of participants achieving at least a 50% reduction in seizure frequency from baseline during the 12-week home-based hyperthermic baths period.
Change in Seizure Frequency
Change in the frequency of epileptic seizures from baseline to the 12-week home-based hyperthermic baths period.
Seizure-free Days
Number of days without epileptic seizures during the 12-week treatment period.
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